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临床试验/NCT03389919
NCT03389919Unknown3 期

EFFECTIVENESS AND SAFETY OF INTRAOSSEOUS ADMINISTRATION OF MESENCHYMAL STORMAL CELLS FOR PRIMARY GRAFT FAILURE AFTER ALLOGENEIC STEM CELL TRANSPLANTATION

National Research Center for Hematology, Russia2 个研究点 分布在 2 个国家目标入组 20 人开始时间: 2017年1月1日最近更新:
适应症

试验速览

阶段
3 期
入组人数
20
试验地点
2
主要终点
Engraftment

研究概览

简要总结

Multipotent mesenchymal stromal cells (MSCs) participate in the formation of bone marrow niches for hematopoietic stem cells. Donor MSCs can serve as a source of recovery for niches in patients with graft failure (GF) after allogeneic bone marrow (BM) transplantation. Since only few MSCs reach the BM after intravenous injection, MSCs were implanted into the iliac spine. Preliminary results suggest that MSCs participate in the restoration of niches for donor hematopoietic cells or have an immunomodulatory effect, preventing repeated rejection of the graft. Perhaps intraosseous implantation of MSCs contributes to the success of the second transplantation of hematopoietic stem cells and patient survival.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients with primary graft failure after allo-HSCT
  • Available MSC for this patient

排除标准

  • 未提供

结局指标

主要结局

Engraftment

时间窗: 28-day

Engraftment

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Principal Investigator
主要研究者

Elena N.Parovichnikova

Head of BMT department

National Research Center for Hematology, Russia

研究点 (2)

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